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The Global Regulatory Town Hall will bring together regulators from around the world to provide their insights on current issues such as harmonization of the practical application of standards and regulations at the interface between regulatory inspections and assessments (e.g., adoption of harmonized standards from ICH, PIC/S, etc.). Panelists will also discuss the impact of coordination efforts such as ORBIS and ACCESS on the assessment and approval process.
Speaker(s):
David
Churchward,
Global Head Sterility Assurance, Cell and Gene Technologies,
Lonza Biologics